FDA recall D-0927-2023

Product

PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;

Reason for recall

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-07-10

Report date

2023-07-26

Termination date

2023-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Woburn, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0927-2023